Shire to fight NICE

23rd November 2006

UK pharmaceutical company, Shire, is to join two other companies in seeking a judicial review of NICE’s controversial decision over treatments for Alzheimer’s disease.

Shire, along with Eisai and Pfizer, plans to tackle the government watchdog on both the availability of the drug Aricept to Alzheimer patients and the methods they use to analyse the value of all drugs. At the heart of the legal action is the lack of full disclosure of the way in which a drug’s efficacy and cost effectiveness are calculated. The National Institute for Health and Clinical Excellence (NICE) uses computer models developed by independent health technology assessment centres to analyse the costs and benefits of the drugs it examines.

Pharmaceutical companies are required to submit full working versions of the computer simulations they use to justify the benefits of their medicines to NICE, allowing the watchdog to analyse, question and change any assumptions made. But the reverse does not apply, which, the drug manufacturers argue, limits their ability to fight any decisions made by NICE.

In the case of Aricept, NICE decided that the drug could be bought by the NHS for patients with moderate and severe Alzheimer's only. The decision to not provide the drug on the NHS to those with mild Alzheimer’s has badly affected many patients. NICE estimated that for patients with mild Alzheimer's, Aricept costs more than £30,000 per quality-adjusted life year (the threshold it uses to judge whether a treatment is cost effective). However, Eisai's own model suggested a lower figure which justified the drug being available to all sufferers on the NHS.

The pharmaceutical companies have decided to take legal action because they feel is it unfair that they don’t have access to the workable model used by NICE in its decision making. A spokesman from the UK arm of Eisai said, “It's unfair that we have to give NICE our computer simulations but not the other way round."

Nice argues that the case brought by the pharmaceutical companies undermines the intellectual property of the academic centres that own the computer models used in drug assessments.